Edge-to-Edge Technique to Minimize Ovelapping of Multiple Bioresorbable Scaffolds Plus Drug Eluting Stents in Revascularization of Long Diffuse Left Anterior Descending Coronary Artery Disease.

BACKGROUND: Implantation of Drug Eluting Stents (DES) plus bioresorbable scaffolds (BVS) in very long diffuse left anterior descending coronary artery (LAD) disease may be problematic because of multiple devices overlapping. We sought to assess the short and mid-tern outcomes of combined implantation of DES and BVS using a novel "edge-to-edge" technique in patients with diffuse LAD disease. METHODS: Patients with long diffuse LAD disease were enrolled in a prospective registry from 1st August 2014 to 1st August 2015 and treated with IVUS-aided percutaneous coronary intervention using a DES plus a single or multiple BVS using a novel "edge-to-edge" technique. Clinical follow up and invasive follow up driven by clinical justification was performed. RESULTS: Twenty-three patients (5 females, mean age 59.1± 9.1 years) were enrolled. Mean length of LAD disease was 73.1 ± 20.6 mm. Mean number of DES and BVS implanted was 1.2 ± 0.4 and 1.7 ± 1.3, respectively. At a mean follow-up of 11.3 ± 3.8 months, no stent thrombosis or MACE were observed. Angiographic and IVUS follow-up at a mean of 6.6 ± 0.7 months showed no significant angiographic restenosis and no appreciable stent gaps. CONCLUSIONS: In revascularization of long diffuse disease of the LAD, the edge-to-edge implantation technique appears to be feasible resulting in no restenosis or thrombosis on the short-term follow-up. (J Interven Cardiol 2016;29:275-284).

Pathophysiology of paradoxical embolism: evaluation of the role of interatrial septum anatomy based on the intracardiac echocardiography assessment of patients with right-to-left shunting.

BACKGROUND: Detailed anatomic variants of the interatrial septum in patients with right-to-left shunt and contribution of specific anatomies to the risk of ischaemic recurrences has not yet been comprehensively classified. OBJECTIVE: To report a classification of the anatomic variants of the interatrial septum as observed by intracardiac echocardiography and its correlation with clinical and functional characteristics. METHODS: We retrospectively reviewed the medical and instrumental data of 520 consecutive patients (mean age 44±15. 5 years, 355 women) who had over a 10-year period undergone intracardiac echocardiography and right-to-left shunt catheter-based closure. The four main features used to analyse were: (a) diameter of the oval fossa, (b) presence and length of the channel, (c) presence and degree of atrial septal aneurysm, and (d) rim thickness. The presence of Eustachian valve was also tabulated. RESULTS: The combinations of interatrial septum anatomical features were classified into six main anatomical subgroups. Recurrent embolism, multiple ischaemic foci on brain magnetic resonance imaging, high grade shunt, and permanent shunt before transcatheter closure procedure were associated with type 2, type 4, and type 6. Type 4 anatomical subtype (OR 4.1, 1.5-8 [95% CI], p<0.001) and type 2+presence of Eustachian valve (OR 4.3, 1.6-9 [95% CI], p<0.001) were the strongest predictors of recurrent ischaemic events before transcatheter closure. CONCLUSION: Our study showed that interatrial septum anatomy greatly differs among patients with right-to-left shunt, as well as the risk of ischaemic recurrences in different anatomies.

Clinical, hemodynamic, and intracardiac echocardiographic characteristics of secundum atrial septal defects-related paradoxical embolism in adulthood.

BACKGROUND: Paradoxical embolism associated with secundum atrial septal defect (sASD) is a relatively rare but well-known occurrence. The purpose of our study is to report the clinical, hemodynamic, and anatomical features assessed by intracardiac echocardiography (ICE) of sASD as related to paradoxical embolism. METHODS: Five hundred thirty-seven patients (mean age 48 ± 19.0 years) admitted for transcatheter repair of interatrial shunts were enrolled in a prospective registry over a 10-year period (September 2003-September 2013). All patients underwent transesophageal echocardiography, complete right and left catheterization, prior to the device-based procedure. ICE was performed in all patients in order to investigate the interatrial septum anatomy and to monitor device implantation. These results were compared with the data of patients with patent foramen ovale (PFO) patients and nonemboligenous sASD admitted at the same time period. RESULTS: Twenty-four patients (6.2%) out of 386 who underwent transcatheter repair for paradoxical embolism had a secundum ASD. The defects were cribrosus in 41.6% (10/24). All single sASD (58.3%) had a peculiar anatomical feature a so-called flat elliptical shape with a major axis of 7.6 ± 2.4 and minimal axis of 2.5 ± 1.6 mm. Patients with sASD-related paradoxical embolism had a higher frequency of deep venous thrombosis compared to PFO patients. In comparison to nonemboligenous sASD, such patients had lower mean pulmonary pressure and smaller defects. CONCLUSION: sASD related to paradoxical embolism had peculiar clinical, hemodynamic, and anatomical characteristics, which classified such defects in the middle of the spectrum between nonemboligenous secundum ASD and PFO.

Strategies to overcome hostile subclavian anatomy during transradial coronary angiography and interventions: impact on fluoroscopy, procedural time, complications, and radial patency.

BACKGROUND: Hostile anatomy of the subclavian artery (severe tortuosity and/or heavy calcification) remains a significant obstacle for the transradial approach during coronary angiography and interventions. OBJECTIVE: To assess impacts on fluoroscopy and procedural times, complications, and radial artery patency in patients with hostile subclavian anatomy by using multiple catheter-guide techniques. METHODS: We retrospectively reviewed the medical and equipment data of 4,580 consecutive patients (mean age 74.4 ± 26.7 years, 49.5% females) who have been referred for transradial coronary angiography and/or interventions within the last 3 years (September 2010-September 2013). In order to overcome the strangling hold of a hostile subclavian artery, 2 techniques have been used: (1) for a coronary angiography-only procedure, a double mother and child technique; (2) for percutaneous coronary intervention, a triple mother and child technique. RESULTS: Ninety-five patients (2.1%) from the entire study population exhibited a hostile subclavian artery. Fifty-two patients (1.1%) underwent coronary angiography only and 43 patients (1%) underwent interventions requiring the use of the above double or triple mother and child techniques, respectively. The 2 techniques were successful in 94.7% of patients (90/95 patients). The procedural time was significantly longer in the patients with hostile subclavian artery while there were no differences in the fluoroscopy time. The radial artery was patent at 30 days in 92.6% of patients (88/95 patients). CONCLUSION: Our data showed that in the presence of hostile subclavian anatomy, the mother and child techniques appeared safe and effective, allowing for the completion of the intended procedure.

Usefulness of intracardiac echocardiography with a mechanical probe for catheter-based interventions: a 10-year prospective registry.

BACKGROUND: The clinical outcome benefit of intracardiac echocardiography (ICE) with a mechanical probe during congenital heart disease interventions has not been fully investigated. We reported the long-term results of a prospective registry of interatrial shunt closure guided by mechanical ICE. METHODS: We enrolled 537 patients (mean age 48 ± 19.0 years, 378 females) submitted to ICE-aided procedures in a prospective registry over a 10-year period (September 2003-September 2013). All patients underwent transesophageal echocardiography (TEE) before the planned procedure. We evaluated (1) structure identification capability, (2) fossa ovale and interatrial septum component measurement, (3) procedure monitoring capability, (4) procedural and fluoroscopy times, and radiograph dose, (5) probe-related complications. RESULTS: ICE was successfully performed and was able to correctly identify the structures previously assessed by TEE in all patients. In 24 patients (4.5%), ICE allowed better anatomy definition than TEE. In 35 other patients (6.5%), ICE identified structures not observed by TEE, which led to change indications to interventions or the operative technique to be used. In 131 patients (24.4%), ICE evaluation led to change the planned device to be implanted. There was only one probe-related complication (0.2%). CONCLUSIONS: Mechanical ICE may offer a valid alternative to conventional TEE in guiding congenital heart disease interventional procedures.

Impact of interatrial septum anatomic features on short- and long-term outcomes after transcatheter closure of patent foramen ovale: single device type versus anatomic-driven device selection strategy.

BACKGROUNDS: We reported the short- and long-term results of our institutional single center registry Interatrial Septum Interventions Study (ISIS) about the impact of different anatomic characteristics and related device selection in patent foramen ovale (PFO) closure. METHODS: Over a 9 year period (September 2003-September 2012) we prospectively enrolled 340 consecutive patients (mean age 44 ± 15. 5 years, 198 females) who had been referred to our center for PFO catheter-based closure. The first 105 patients received a single type of device independently from the anatomy (single device strategy). The remaining 235 patients received a different device based on intracardiac echocardiographic study of interatrial septum anatomy (anatomic strategy). RESULTS: Immediate success rate was 100% in both groups, whereas the rate of immediate complications was 10.4% and 2.5% (P<0.01) in the single strategy group and anatomic strategy group, respectively. During a mean follow-up of 59.3 ± 28.9 months, the occlusion rate was 86.6% and 94%, whereas the incidence of recurrences was 1.8% and 0% in the single device strategy group and anatomic strategy group, respectively. CONCLUSION: The results from ISIS registry showed that anatomy of interatrial septum associated with PFO is quite complex leading to an increased rate of complications and a slightly lower closure rate if treated with a single device strategy.

Safety and long-term outcome of modified intracardiac echocardiography-assisted "no-balloon" sizing technique for transcatheter closure of ostium secundum atrial septal defect.

BACKGROUND: The need for sizing the secundum atrial septal defect (ASD) with the balloon sizing technique is still debated at least in adult patients. We sought to prospectively evaluate the effectiveness of intracardiac echocardiography (ICE)-aided sizing technique for transcatheter closure of secundum ASD, without using a balloon sizing. METHODS: In a prospective 5-year registry, we enrolled 81 patients (mean age 48 ± 13.7 years, 54 females) who had been referred to three different centers for atheter-based closure of secundum ASD. Eligible patients underwent ICE study and closure attempt. In a preliminary group of 21 patients, sizing balloon was performed under ICE guidance to assess the value of rim thickness necessary for device anchorage. In the remaining 60 patients, the retrieved value of the rim thickness was measured on ICE and used as key points to measure the defect and select the device. RESULTS: In the preliminary group of patients, the value of thickness at point of initial deflection by the balloon was 1.23 ± 0.1 mm. ASD diameter in the study group was measured at the point of rim with at least 1.2 mm and the mean ASD diameter was 26.2 ± 10.1 mm. Rates of procedural success, predischarge occlusion, and major complications rate were 100%, 93.3%, and 0%, respectively. On mean follow-up of 5.4 ± 1.8 years, the occlusion rate was 98.7% with no long-term complications. CONCLUSIONS: Our novel ICE-sizing technique appears to be safe and effective in adult patients, thus eventually minimizing overestimation, costs, and potential complications of balloon sizing.

Premere occlusion system for transcatheter patent foramen ovale closure: mid-term results of a single-center registry.

BACKGROUND: Transcatheter closure of patent foramen ovale (PFO) with rigid devices may be problematic in patients with long channel PFO: alternative devices with asymmetrical opening and more physiological positioning may be preferable in such cases. We present the mid-term results of transcatheter closure of PFO with Premere Occlusion System, a device studied for this specific anatomy, in a single-center registry of adults with previous cerebral ischemia. METHODS: During a 53-months period (July 1, 2005 to December 1, 2009) 70 patients (48 females and 22 males, mean age 38 ± 6.7 years) with previous stroke were admitted in our center for transcatheter closure of PFO with Premere Occlusion System on the basis of absence of moderate or severe atrial septal aneurysm (ASA) on Transesophageal echocardiography and intracardiac echocardiography (< 3RL or 3LR ASA and length of PFO channel >10 mm). RESULTS: The procedure was successful in all of the patients with no peri-operative and in-hospital complications. Forty-six 20 mm and twenty-four 25 mm Premere devices were implanted. Rates of procedural success, predischarge occlusion, and complication were: 100%, 95.7% and 0%, respectively. On mean follow-up of 40 ± 10.9 months (range 6-54), the follow-up occlusion rate was 98.5%. During follow-up, no cases of permanent atrial fibrillation, aortic/atrial erosion, device thrombosis, or atrioventricular valve inferences were noted. CONCLUSION: The mid-term outcomes of our registry suggests that the Premere Occlusion System may be an excellent device for patients with long-channel PFO and absence of moderate/severe ASA, offering a physiological and anatomically respective closure of PFO also in patients with hypertrophic rims.

Endovascular treatment of diabetic foot syndrome: results from a single center prospective registry using mixed coronary and peripheral techniques and equipment.

To assess the long-term results of interventional treatment of diabetic foot using mixed coronary and peripheral equipments and techniques. The interventional diabetic foot syndrome treatment is rapidly becoming the therapy of choice in such patients, but proper materials and techniques are still debated. From January 2006 to December 2010, we prospectively enrolled 220 diabetic patients (78.5 ± 15.8 years, 107 females, all with Fontaine III or IV class), referred to our center for diabetic foot syndrome and severe limb ischemia. Mixed coronary and peripheral guidewires and balloons techniques were used. Doppler ultrasonography and foot transcutaneous oxygen pressure (TCPO2) before and after the procedure were calculated as well as the amputation rate. The preferred approach was ipsilateral femoral antegrade in 170/220 patients (77.7%), contralateral cross-over in 40/220 patients (18.8%), and popliteal retrograde + femoral antegrade in 10/220 patients (4.5%). The techniques included combined use of coronary and dedicated peripheral guidewires and coronary and peripheral dedicated balloons. Balloon angioplasty was performed in 252 legs (32 patients with bilateral disease): the procedure was successful in 239/252 legs with an immediate success rate of 94.8% and a significant improvement in TCPO2 and ankle-brachial index with ulcer healing in 233/252 legs (92.4%). The freedom from major amputation was 82.8% at a mean follow-up of 3.1 ± 1.8 years (range 1 to 5 years). The endovascular diabetic foot syndrome treatment using mixed coronary and peripheral materials and techniques seems to lead to high immediate success and limb salvage rates compared to historical series.

Incomplete aneurysm coverage after patent foramen ovale closure in patients with huge atrial septal aneurysm: effects on left atrial functional remodeling.

BACKGROUND: Large devices are often implanted to treat patent foramen ovale (PFO) and atrial septal aneurysm (ASA) with increase risk of erosion and thrombosis. Our study is aimed to assess the impact on left atrium functional remodeling and clinical outcomes of partial coverage of the approach using moderately small Amplatzer ASD Cribriform Occluder in patients with large PFO and ASA. METHODS: We prospectively enrolled 30 consecutive patients with previous stroke (mean age 36 +/- 9.5 years, 19 females), significant PFO, and large ASA referred to our center for catheter-based PFO closure. Left atrium (LA) passive and active emptying, LA conduit function, and LA ejection fraction were computed before and after 6 months from the procedure by echocardiography. The preclosure values were compared to values of a normal healthy population of sex and heart rate matched 30 patients. RESULTS: Preclosure values demonstrated significantly greater reservoir function as well as passive and active emptying, with significantly reduced conduit function and LA ejection fraction, when compared normal healthy subjects. All patients underwent successful transcatheter closure (25 mm device in 15 patients, 30 mm device in 6 patients, mean ratio device/diameter of the interatrial septum = 0.74). Incomplete ASA coverage in both orthogonal views was observed in 21 patients. Compared to patients with complete coverage, there were no differences in LA functional parameters and occlusion rates. CONCLUSIONS: This study confirmed that large ASAs are associated with LA dysfunction. The use of relatively small Amplatzer ASD Cribriform Occluder devices is probably effective enough to promote functional remodeling of the left atrium.

Left atrial dysfunction in patients with patent foramen ovale and atrial septal aneurysm scheduled for transcatheter closure may play a role in aura genesis.

BACKGROUND: It has been suggested that a left atrial (LA) dysfunction induced by large shunt and large atrial septal aneurysm (ASA) may act as a concurrent mechanism of arterial embolism in patients with patent foramen ovale (PFO) and prior stroke. We aimed to evaluate the potential contribution of this mechanism as trigger of migraine in patients with PFO. METHODS: From January 2007 to September 2009, we prospectively enrolled subjects with migraine who underwent percutaneous PFO closure. Echocardiographic parameter of LA dysfunction was evaluated: pre- and postoperative values were compared to values of different sex and heart rate matched populations: 30 healthy patients, 21 migraine patients without PFO (MwoPFO), and a group of 25 PFO patients without migraine (PFOwoM). The Migraine Disability Assessment Score (MIDAS) was used to assess the incidence and severity of migraine. RESULTS: Forty-five patients (38 females, mean age 38 +/- 6.7 years, mean MIDAS 35.8 +/- 4.7, and 28 patients with migraine with aura) fulfilled the inclusion criteria. After successful percutaneous closure (mean follow-up of 18.2 +/- 4.8 months), PFO closure remained complete in 95%; 35 of 45 patients reported resolution or amelioration of migraine (mean MIDAS score 12.3 +/- 8.8, P < 0.03). All patients with aura reported aura resolution. Preclosure values demonstrated significantly greater LA dysfunction, when compared with healthy and MwoPFO groups. Among patients in the study group, only patients with migraine with aura showed LA dysfunction comparable to PFOwoM patients. CONCLUSION: This study suggests that LA dysfunction probably does not contribute to migraine itself but may play a role in the genesis of aura symptoms.

Patent oval foramen transcatheter closure: results of a strategy based on tailoring the device to the specific patient's anatomy.

BACKGROUND: Usually the literature results for device-closure of patent oval foramen concern a single type of device or different devices implanted without anatomical preferences. We propose a strategy of device type and selection based on intra-cardiac echocardiography measurements of inter-atrial septum characteristics. METHODS: We prospectively enrolled 100 consecutive patients with a mean age of 43 plus or minus 15.5 years, 68 females, who had been referred to our centre for catheter-based closure of inter-atrial shunts over a 48-month period. On the basis of intra-cardiac echocardiography findings the operators selected the Amplatzer Occluder family (AGA Medical Corporation) or the Premere Closure System (St Jude Medical Inc.). Determinants of the selection process were presence and extension of atrial septal aneurysm, tunnel length, rims length, and thickness, presence of additional fenestrations. RESULTS: According on intra-cardiac echocardiography study, 26 patients have a long channel patent oval foramen, 44 patients had a large atrial septal aneurysm (more than four RL), 24 patients had a moderate atrial septal aneurysm (more than two RL but less than four right-to-left), and six patients had hypertrophic rims. Thus, the Amplatzer PFO Occluder was selected in 24 patients, the Amplatzer ASD Cribriform Occluder in 44 patients, and the Premere device in 32 cases. No aortic erosions, device thrombosis, or recurrent ischaemic cerebral events were observed. Pre-discharge and follow-up occlusion rates were 91% and 96%, respectively. CONCLUSIONS: Our study suggested that such strategy driven from identification and measurements of the right atrium and inter-atrial septum components resulted in low complications and high-success rates, mandatory conditions when facing with otherwise healthy subjects, such as the patients with patent oval foramen.

[Patent foramen ovale: a benign anatomical variant that can become a disease]. / Il forame ovale pervio: quando una variante anatomica diventa patologia.

Patent foramen ovale (PFO) is mostly considered a benign anatomical variant but in presence of a significant right to left shunt, it can represent the substrate for embolic disease as cryptogenetic stroke, decompression syndrome, myocardial infarction with normal coronary arteries, etc. A diffuse therapeutic option consists in the PFO transcatheter closure: a procedure with no dedicated guidelines. We retrospectively studied demographic characteristics, clinical remarks, indications and morphological findings in 143 patients who underwent percutaneous PFO closure in the Interventional Cardiology Unit of the Rovigo General Hospital between 2006 and 2009.

Risk of Dislodgement of Ultrathin Drug Eluting Stents Versus Thick Drug Eluting Stents.

Modern ultrathin struts drug eluting stents (DES), due to their constructive characteristics, might be more prone to stent dislodgment than the old thick DES. Our study is aimed to retrospectively analyze and compare the incidence and outcomes of stents dislodgment in thick (TSS) and ultrathin strut stents (USS).We retrospectively analyzed the procedural and medical data of 8,564 consecutive patients (mean age 64.3 ± 11.2 years old, 4442 males) who underwent percutaneous coronary intervention with DES implantation in our Institution between 1st January 2005 to 1st January 2020. Overall, 25,692 (mean of 3.2 stent for patients) have been implanted over the study period (10648 TSS and 15044 and USS, respectively). Stent dislodgment globally occurred in 0.56% of the implanted stents (0.28% vs 0.78%, p <0.001 for TTS and USS, respectively). Coronary artery calcifications, ostial lesion, coronary artery tortuosity, and a lesion length >25 mm were independent predictors of type I and II USS dislodgments. At 12 months follow up, the rate of target lesion failure was higher in the TTS group (30.7 vs 12.7 %, p <0.001). Stent dislodgement is unusual in the modern era but is more frequent using USS than TTS DES.

Embolic implications of combined risk factors in patients with patent foramen ovale (the CARPE criteria): consideration for primary prevention closure?

BACKGROUND: Large patent foramen ovale (PFO), spontaneous right-to-left shunt, large atrial septal aneurysm (ASA), coagulation abnormalities, and prominent eustachian valve (EV) have all been independently suggested as risk factors for recurrent stroke. We sought to retrospectively evaluate risk of stroke and impact of transcatheter PFO closure in patients with concurrent large PFO, spontaneous right-to-left shunt, large ASA, coagulation abnormalities, and prominent EV. METHODS: Between March 2006 and October 2008, 36 (mean age 44 +/- 10.9 years, 28 females) out of 120 consecutive patients referred to our center for transcatheter PFO closure had concomitant diagnosis of (a) large PFO on transcranial Doppler (TCD) and transesophageal echocardiography (TEE), (b) spontaneous right-to-left shunt on TCD, (c) large ASA, (d) prominent EV, and (e) coagulation abnormalities. All patients fulfilled the standard current indications for transcatheter closure and underwent preoperative TEE and brain magnetic resonance imaging (MRI), with subsequent intracardiac echocardiographic-guided transcatheter PFO closure. RESULTS: Compared to the remaining PFO population in the same period, patients with all five concomitant features had more ischemic brain lesions on MRI, previous history of recurrent stroke, more frequently a history of venous thromboembolism, and more severe migraine with aura. The concomitance of all the features confers the highest risk of recurrent stroke (OR 9.9, 3.0-18 [95% CI], P < 0.001). CONCLUSIONS: Despite its small sample size and nonrandomized retrospective nature, this is the first study to suggest that patients with concurrence of all the investigated characteristics have potentially a higher risk of stroke compared to controls. We thus propose the CARP criteria as a basis for further larger, longitudinal studies to assess the potential benefits of transcatheter closure in this patient subset in the absence of clinical recurrent stroke.

Carotid artery angioplasty and stenting in patients with hostile anatomy: the multi-wire technique.

PURPOSE: To describe the multi-wire technique that facilitates cannulation of the carotid artery during angioplasty and stenting in patients with difficult neck anatomy. TECHNIQUE: When cannulation of the common carotid artery (CCA) was not effective with a 5-F diagnostic mammary artery catheter and standard single-wire technique, a 0.035-inch hydrophilic guidewire was advanced into the external carotid artery (ECA) with the aid of the road map technique and 6-mL injections of contrast. The catheter was exchanged for an 8-F MPA guiding catheter. If the first attempt to advance the guide catheter failed, an additional 2 or 3 hydrophilic guidewires were placed within the ECA to advance the guiding catheter to the CCA, paving the way for carotid angioplasty. Of 140 patients referred to our center with hostile neck anatomies, this technique had been employed in 30 (21%) patients (26 men; mean age 78+/-6 years): 15 (50%) had type III aortic arch, 7 (23%) had severe tortuosity of the CCA, and 8 (27%) had angulated takeoffs of the carotid or internal arteries. The 2-wire technique was used in 17 patients, 3 wires in 9 patients, and 4 wires in 4 patients. Successful cannulation and correct stent deployment were achieved in all patients. Fluoroscopy time was longer in hostile neck patients compared with others (7.2+/-3.1 versus 3.8+/-2.3 minutes, p<0.01). CONCLUSION: The multi-wire techniques appear to be a safe and effective method to aid cannulation and angioplasty of carotid arteries in patients with hostile neck anatomy.

Transcatheter interatrial shunt closure as a cure for migraine: can it be justified by paradoxical embolism-risk-driven criteria?

BACKGROUND: Some ongoing trials have suggested that closure of the patent foramen ovale (PFO) may reduce migraine symptoms. We sought to assess the safety and effectiveness of migraine treatment by means of PFO transcatheter closure using paradoxical embolism risk-driven criteria. METHODS: We enrolled 75 patients (48 women and 27 men, mean age 40 +/- 3.7 years) who were referred to our center over a 12-month period for a prospective study to evaluate severe disabling migraine, despite antiheadache therapy and the PFO. Migraine Disability Assessment Score (MIDAS) was used to assess the incidence of migraine headache and severity. Criteria for intervention included all of the following: basal shunt, curtain shunt pattern on transcranial Doppler, presence of interatrial septal aneurysm, 3 to 4 class MIDAS score, symptomatic significant aura, coagulation abnormalities, migraine refractory to conventional drugs. RESULTS: On the basis of the inclusion criteria, we shortlisted 20 patients (12 women, mean age 35 +/- 6.7 years, mean MIDAS score 38.9 +/- 5.8) for transcatheter closure of PFO and excluded the rest who were referred to the neurologist for medical therapy. The procedure was successful in all of the patients with no perioperative or in-hospital complications. After a mean follow-up of 10 +/- 3.1 months (range 6-14), all patients' migraine symptoms improved (mean MIDAS score 3.0 +/- 2.1, P < 0.03) with PFO complete closure in all patients on transesophageal and transcranial Doppler ultrasound. CONCLUSION: In this small pilot series, we adopted the criteria which in our opinion best reflected the risk of paradoxical embolism in these patients. By adopting the proposed criteria, primary transcatheter closure of the PFO resulted in a significant reduction in migraine.

Transcatheter intracardiac echocardiography-assisted closure of interatrial shunts: complications and midterm follow-up.

OBJECTIVE: It has been suggested that intracardiac echocardiography (ICE) improves the safety and effectiveness of transcatheter device-based closure of interatrial shunts, but the impact of this technique on midterm follow-up is unknown. We sought to prospectively evaluate midterm follow-up results of ICE-aided transcatheter closure of interatrial shunts in adults. METHODS: Over a 48-month period, we prospectively enrolled 140 consecutive patients (mean age 43 +/- 15. 5 years, 98 females) who had been referred to our center for catheter-based closure of interatrial shunts. All patients were screened with transesophageal echocardiography (TEE) before the operation. Patients who met the inclusion criteria underwent ICE study and attempted closure. Immediate success rates, predischarge occlusion rates, complication rates, as well as fluoroscopy and procedural times, patients' radiological exposure, midterm complication rates, and midterm occlusion rates were evaluated. RESULTS: One hundred patients out of 140 (71.4%) underwent an attempt at transcatheter closure. After ICE study and measurements, the TEE-planned device type and size was changed in 31 patients with patent foramen ovale whereas the TEE-planned device size was changed in 41 patients with atrial septal defect (globally 72%). Procedural success rate, predischarge occlusion rate, and complication rate were 99, 90.7, and 12%, respectively. On mean follow-up of 36.6 +/- 14.8 months the follow-up occlusion rate was 96.5%. No aortic erosion or device thrombosis was observed. CONCLUSIONS: ICE-guided interatrial shunt transcatheter closure is safe and effective and appears to have excellent midterm results thus avoiding the complications caused by device oversizing, such as aortic erosion and device thrombosis.

Education, and obtaining of informed consent, using multimedia before adults with congenitally malformed hearts are submitted to transcatheter interventions.

BACKGROUND: Multimedia programmes relating to education and consents may be useful for decreasing anxiety during catheter-based repair in patients with congenitally malformed hearts. OBJECTIVE: Our study was aimed at evaluating the impact of multimedia protocols for education of a population of consecutive patients with congenitally malformed hearts prior to transcatheter repair. METHODS: Between September, 2006, and May, 2008, we enrolled 100 consecutive patients, with a mean age of 45 +/- 19 years, of whom 69 were female, for catheter-based repair of their congenitally malformed hearts. In the first 50 patients, we used a written form for informed consent sent to the patients 15 days before the procedure, coupled with a personal interview of 30 minutes. In the subsequent 50 patients, we used multimedia protocol for education, comprising a booklet of 4 pages containing a simple and brief explanation of the intervention, and a digital film of 4 minutes showing the transcatheter procedure with a commentary provided by the referring physician, prior to obtaining the signature for informed consent. We then compared the scores for anxiety, the pre-operative heart rate, the frequency of vaso-vagal episodes, and the need for conscious sedation between the two groups. RESULTS: Patients who underwent preconditioning using the multimedia programme were significantly less anxious, and had significantly lower heart rates. Vaso-vagal episodes were also significantly less in this group, with no episodes compared to 14% in those providing standard informed consent. Conscious sedation was needed more frequently in those providing standard informed consent. CONCLUSION: Our brief study suggests that a comprehensive multimedia programme of preparation increases the tolerability, and decrease the emotional state, of adults about to undergo catheter-based interventions for congenital cardiac disease.